NIRA Temp is a wearable wireless electronic thermometer to monitor body temperature. It is attached to the body in the underarm area with and adhesive patch and monitors body temperature sending data to a nearby mobile device (Android or iOS) so the data and their history can be displayed on the mobile device screen. If the temperature exceeds a designated threshold, a warning or alarm will be provided to the user and as well as any persons or organizations as designated by the user in app settings.
NIRA Temp - How It Works
The device has its own indications with color LEDs. Normal temperature is indicated as flashing green LED and fever is indicated as flashing red LED. Warnings may be indicated with a flashing orange LED.
The device is powered by a small non-rechargeable coin cell battery designed to work for a minimum of 12 months of continuous operation. NIRA Temp will consume less battery power when stored before so that operational use should remain at approximately 12 months or more. NIRA Temp is designed to be worn during waking hours and during sleeping. Full 24 hours usage is recommended so that the NIRA algorithm can best determine health concerns based on deviations from baseline temperatures at all hours. The device is waterproof rated at IP67, which means that it can be safely immersed underwater for up to 30 minutes, depth not to exceed 1.5 meters. However, the device is not recommended to be used in water as the temperature is less accurate and the device may be lost if the adhesive detaches.
The device is mounted on the body in the center of the armpit area such as metal part which is connected to the internal temperature sensor is touching the skin and opposite side is contacting the adhesive pad.
Normally it takes up to 10 to 20 minutes for the thermometer to settle in thermal equilibrium on the body, so the temperature measurements during the initial 10 to 20 minutes are preliminary and are below the actual armpit skin temperature. This is normal. Temperature is measured once per minute and NIRA Temp device broadcasts Bluetooth information in an encrypted and private format. Any mobile device running the NIRA Temp app can receive the encrypted temperature information and push it to the cloud database without sharing any confidential information. The user’s mobile phone reads the temperature information from the cloud server only related to them and those who have shared their information and displays it for the user. If temperature is above a set threshold for fever, the mobile phone will provide a notification to the user.
If for some period of time the mobile phone is out of range to receive the broadcast information from the thermometer, the device continues to measure and store results in within its internal memory. When the mobile phone is back in range, it can connect with the NIRA Temp device and receive all stored information from the device and fill in any missing information not previously pushed to the cloud. It is common for stored information to be in intervals of approximately every 10 minutes, not every minute as often seen during real-time active phone communications.
The Science of Body Temperature Measurement
There are several accepted locations for direct medical temperature measurements – oral, rectal, armpit and ear. For a wearable thermometer armpit looks like the only practical location. The table below gives the normal ranges of body temperature for adults and children according to Welch Allen thermometer manufacturer:
|
0 - 2 Years |
3 - 10 Years |
11 - 65 Years |
Over 65 Years |
|
|
Oral |
95.9 - 99.5°F |
95.9 - 99.5°F |
97.6 - 99.6°F |
96.4 - 98.5°F |
|
Rectal |
97.9 - 100.4°F |
97.9 - 100.4°F |
98.6 - 100.6°F |
97.1 - 99.2°F |
|
Armpit |
94.5 - 99.1°F |
96.6 - 98.0°F |
95.3 - 98.4°F |
96.0 - 97.4°F |
|
Ear |
97.5 - 100.4°F |
97.0 - 100.0°F |
96.6 - 99.7°F |
96.4 - 99.5°F |
The NIRA Temp graph displays two data point lines. The colored, bolded line is your NIRA temperature trend line which is a better, smoothed approximation of your temperature made for your convenience. The light gray line is your measured temperature from the NIRA Temp device which may vary based upon changes in your arm position.
Normal body temperature readings will vary within these ranges depending on the following factors:
- a person’s age and sex
- the time of day, typically being lowest in the early morning and highest in the late afternoon
- high or low activity levels
- food and fluid intake
- for females, the stage in their monthly menstrual cycle
There is no reliable evidence for the difference between armpit and oral measurement locations. (Sund‐Levander, et al (2002). "Normal oral, rectal, tympanic and axillary body temperature in adult men and women: a systematic literature review." Scandinavian journal of caring sciences 16(2): 122-128)
According to yet another source, US Food and Drug Administration (FDA) performed a study comparing three different brands of thermometer (Vesnovsky, O., et al (2014). "Performance Testing of Fast Read Digital Thermometers." Journal of Medical Devices-Transactions of the Asme 8(3): 30905-30905.) and found different shift between oral and armpit measurements for different brands:
What is considered a fever?
According to information in Healthline, adults typically have a fever if their body temperature, measured orally, increases to 100.4°F (38°C). This is called a low grade fever. A high grade fever happens when your body temperature is 103°F (39.4°C) or above. The NIRA Temp sets the equivalent low-grade fever at 100.0°F (37.8°C). NIRA Temp uses 100.0 as the default level to send Alert notifications. Alert is meant to be an indication whereby the user should seek medical attention to determine if the user is ill and then consider the appropriate treatment. A Warning level is set by an algorithm within NIRA Temp which is meant to provide some insight for the use that their baseline temperature has changed significantly, but still may be within a safe range. The user can change the Warning and Alert temperature thresholds, based on individual health history and known temperature daily and monthly patterns as the user sees fit.
Privacy & Handling of Confidential Information
The device, as well as mobile application and servers store personal health information (PHI) that falls under definition of Medical Device Data Storage (MDDS under 21 CFR 880.6310). This standard covers mobile apps that transfer, store, convert formats, and display medical device data without modifying the data and do not control or alter the functions or parameters of any connected medical device.
The PHI information storage is not regulated by Health Insurance Portability and Accountability Act (HIPAA). According to the HIPAA regulation, “Only health plans, health care clearinghouses and most health care providers are covered entities under HIPAA. For more information see see link.
In EU information protection is regulated by General Data Protection Regulation (GPDR) and in California by Consumer Privacy Act (CCPA).Therefore special measures are implemented in the design to insure data integrity and safety, including cybersecurity threats such as unauthorized access or modification of the data. Such measures include proper authentication and authorization of access, encryption, data integrity confirmation (in storage and transmission). The protection is implemented in all levels – communication between mobile device and the thermometer, mobile applications, communication between mobile device and server and storage and handling information in the server.
For more information regarding how NIRA Temp handles your data see NIRA Privacy Policy and Terms and Conditions.
NIRA Temp Regulatory Status
The device was tested and found compliant with the FDA and FCC recognized standards, including:
ISO 10993-10:2010 Biological evaluation of medical devices- Part 10: Tests for irritation and skin sensitization
ASTM E112:2018 Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature
AAMI / ANSI ES60601-1:2005/(R) 2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)
Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance.
IEC 60601-1-2:2014, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests.
ISO 80601-2-56: 2017, Medical Electrical Equipment - Part 2-56: Particular Requirements For Basic Safety And Essential Performance Of Clinical Thermometers For Body Temperature Measurement.
IEC 60601-1-11:2015 Medical electrical equipment- Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical system used in the home healthcare environment
FCC Part 15 Rule 247 for intentional radiation of radio frequency
ASTM D4169-14 Standard Practice for Performance Testing of Shipping Containers and Systems
In April 2020 the US government issued an Emergency Use Authorization allowing commercial sale of clinical thermometers without obtaining 510(k) clearance, assuming that company has appropriate quality system and the product is compliant with the above mentioned standards. The FDA clearance will be obtained later and the product labeling will be updated at that time to reflect it.
NIRA Temp is suitable for clinical use as a medical thermometer.
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